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    P3.1 Validation to Manufacturing

    Home » P3.1 Validation to Manufacturing
     Your Medical Device Is Not Ready for a Human Factors Validation Study Until You Complete These 4 Steps
    By Elyse Hallett
    In Human Factors & Usability Testing, Medical Product Design
    Posted February 20, 2023

    Your Medical Device Is Not Ready for a Human Factors Validation Study Until You Complete These 4 Steps

    If your human factors validation study is inadequate, the FDA can bounce your entire submission back. Consequently forcing you to revise your submission file — or worse, your actual design — and [...]

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     3 Steps to an FDA-Worthy Human Factors Validation Study
    By Elyse Hallett
    In Human Factors & Usability Testing, Medical Product Design
    Posted November 1, 2022

    3 Steps to an FDA-Worthy Human Factors Validation Study

    Human factors validation testing shows you’ve done your due diligence to mitigate identified hazards and the resulting harms your device might cause users and patients. For the majority of [...]

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     4 Advantages of Working With One Medical Device Development Partner From Concept to Completion
    By Hank Kohl
    In Medical Product Design
    Posted November 15, 2021

    4 Advantages of Working With One Medical Device Development Partner From Concept to Completion

    Of course, you’ve been feeling the landscape shift for years. That’s why you’re already so concerned about time to market and first mover advantage. The problem is that your medical device [...]

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    MindFlow Design LLC dba MPE Inc. is a leading medical product development firm for Medical, Life Sciences, and Consumer Health Companies. We aspire to introduce powerful, intuitive healthcare technologies to the world.
    INSIGHTS
    • The Market Adoption Landscape Has Shifted. Here’s Who to Consider When Creating Your Medical Device Design Strategy.
      The Market Adoption Landscape Has Shifted. Here’s Who to Consider When Creating Your Medical Device Design Strategy.
      May 3, 2023
    • Essentials of a Medical Device Manufacturing Plan
      Essentials of a Medical Device Manufacturing Plan
      March 22, 2023
    • The Only Human Factors Planning Guide You Need
      The Only Human Factors Planning Guide You Need
      March 22, 2023
    • Your Guide to FDA Device Classification
      Your Guide to FDA Device Classification
      March 22, 2023
    • Your Medical Device Is Not Ready for a Human Factors Validation Study Until You Complete These 4 Steps
      Your Medical Device Is Not Ready for a Human Factors Validation Study Until You Complete These 4 Steps
      February 20, 2023
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